Nektar Therapeutics (NKTR) announced Monday positive results from the SUMMIT-07 Phase 3 efficacy study of NKTR-181, a first-in-class opioid analgesic.
NKTR-181 is a new chemical entity or NCE that is the first full mu-opioid agonist molecule designed to provide potent pain relief without the high levels of euphoria that can lead to abuse and addiction with standard opioids.
The U.S. Food and Drug Administration or FDA has granted the investigational medicine NKTR-181 Fast Track designation for the treatment of moderate to severe chronic pain.
The SUMMIT-07 study compared twice-daily dosing of NKTR-181 tablets to placebo in the treatment of over 600 patients with moderate to severe chronic low back pain who were new to opioid therapy. The clinical trial met the primary efficacy endpoint of the study in demonstrating significantly improved chronic back pain relief with NKTR-181 compared to placebo. Key secondary endpoints of the study were also met with high statistical significance.
Full data from the SUMMIT-07 study will be presented at a medical meeting in the second half of 2017.
by RTT Staff Writer
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